Determination of useful ranges of mixing conditions for glycerin fatty acid ester by multiple regression analysis

Abstract

The interaction of the effects of the triglycerin full behenate (TR-FB) concentration and the mixing time on lubrication and tablet properties were analyzed under a two-factor central composite design, and compared with those of magnesium stearate (Mg-St). Various amounts of lubricant (0.07-3.0%) were added to granules and mixed for 1-30 min. A multiple linear regression analysis was performed to identify the effect of the mixing conditions on each physicochemical property. The mixing conditions did not significantly affect the lubrication properties of TR-FB. For tablet properties, tensile strength decreased and disintegration time increased when the lubricant concentration and the mixing time were increased for Mg-St. The direct interaction of the Mg-St concentration and the mixing time had a significant negative effect on the disintegration time. In contrast, any mixing conditions of TR-FB did not affect the tablet properties. In addition, the range of mixing conditions which satisfied the lubrication and tablet property criteria was broader for TR-FB than that for Mg-St, suggesting that TR-FB allows tablets with high quality attributes to be produced consistently. Therefore, TR-FB is a potential lubricant alternative to Mg-St. © 2013 The Pharmaceutical Society of Japan.